Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)



Status:Completed
Healthy:No
Age Range:Any
Updated:1/2/2019
Start Date:June 2013
End Date:September 2016

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Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)

The goal of this protocol is to establish a cohort of at least 1500 biologic samples
collected prospectively from patients treated in BMT CTN centers that will be a shared bio
specimen resource for conducting future allogeneic hematopoietic stem cell transplantation
(HCT) correlative studies.

The goal of this protocol is to establish a cohort of biologic samples collected
prospectively from patients treated in BMT CTN centers that will be a shared bio specimen
resource for conducting future allogeneic HCT correlative studies. This resource is designed
to allow genomic, proteomic and transcriptional data to be integrated with high quality
clinical phenotype and outcomes data to identify risk factors for development and severity of
acute GVHD, chronic GVHD, organ toxicity, relapse, mortality, infection and other clinically
significant complications occurring after allogeneic HCT.

To achieve this goal, patients and donors will be recruited and consent obtained at the time
that they enroll on BMT CTN protocols where enrollment occurs at or before transplantation or
prior to start of conditioning for patients enrolled on non-BMT CTN studies or treated as
standard of care. Samples will be collected: (1) from patients and donors pre-transplant;
and, (2) from patients post-transplant on a calendar schedule through the first 3 months
post-HCT. For patients co-enrolled on BMT CTN studies, clinical data will be collected in the
context of the primary transplant protocols. For patients not enrolled on BMT CTN protocols,
clinical data on early post-transplant events will be collected using the same data
collection forms and systems that are used on BMT CTN trials. Additional clinical data for
both BMT CTN and non-BMT CTN patients will be available from data submitted to the Center for
International Blood and Marrow Transplant Research (CIBMTR) using the CIBMTR Comprehensive
Report Forms. This protocol also leverages ongoing pre-transplant donor-recipient sample
collection performed by the CIBMTR and National Marrow Donor Program (NMDP). Success in
establishing this shared resource will inspire future investigator initiated research
proposals and will allow investigators to take advantage of National Institutes of Health
(NIH) funding initiatives.

Inclusion Criteria:

1. Recipients of first allogeneic hematopoietic cell transplants that are transplanted in
U.S. centers that participate in the NMDP/CIBMTR's "Protocol for a Research Sample
Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic
Injuries" and receive a cord blood graft or receive a bone marrow or peripheral blood
graft from a related donor or from an unrelated donor in an NMDP-affiliated Donor
Center or Registry participating in that same protocol.

This transplant and donor center restriction is to allow linkage with pretransplant
donor specimens collected under the NMDP/CIBMTR protocol. Current data indicate that
>90% of donors approached under this protocol agree to provide samples

2. Patients with any malignant or non-malignant hematologic disorder will be eligible for
enrollment on this protocol. A subset of 240 sequential patients with acute leukemia
in first or second remission will also provide research samples for gene expression
studies.

3. Children may participate in this study but must weigh at least 20 kilograms given the
volume (100ml) and number of blood draws during this study. Subjects must weigh at
least 30 kg to provide research samples for gene expression studies (additional 40
ml).

4. All participants or parent/legal guardian must sign an informed consent for this
study.

Because studies using this resource will require linking with clinical data collected by
CIBMTR, all participants or parent/legal guardian must also consent to participate in
"Protocol for a Research Database for Hematopoietic Cell Transplantation and Marrow Toxic
Injuries".

Exclusion Criteria:
We found this trial at
42
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Edmund Waller, MD, PhD
Phone: 404-727-4995
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Joanne Kurtzberg
Phone: 919-668-1102
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1600 SW Archer Rd # M509
Gainesville, Florida 32610
Principal Investigator: John Wingard, MD
Phone: 352-273-8022
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Phone: 212-824-9365
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Eneida Nemecek
Phone: 503-494-0829
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: John Hansen
Phone: 206-667-5111
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Ann Arbor, Michigan 48109
Phone: 734-247-2518
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, Georgia 30342
Principal Investigator: Asad Bashey, MD, PhD
Phone: 404-255-1930
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Javier Bolanos-Meade, MD
Phone: 410-614-6398
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Boston, Massachusetts 02115
Principal Investigator: Vincent Ho
Phone: 617-632-5938
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Buffalo, New York 14263
Principal Investigator: Philip McCarthy, MD
Phone: 716-845-1444
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101 Manning Dr
Chapel Hill, North Carolina 27599
(919) 966-4131
Principal Investigator: Thomas Shea, MD
Phone: 919-966-7746
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
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Chicago, Illinois 60614
Principal Investigator: Sonali Chaudhury, MD
Phone: 312-227-4863
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Cleveland, Ohio 44106
Principal Investigator: Hillard Lazarus, MD
Phone: 216-844-3969
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Ronald Sobecks, MD
Phone: 216-445-4626
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43210
Principal Investigator: Sumithira Vasu
Phone: 614-293-8197
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Ryotaro Nakamura, MD
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Fort Worth, Texas 76104
Principal Investigator: Gretchen Eames, MD
Phone: 682-885-2580
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Alfred Gillio, MD
Phone: 551-996-5600
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, Texas 77030
Phone: 713-441-1450
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Houston, Texas 77030
Phone: 713-745-3055
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Kansas City, Kansas 66160
Principal Investigator: Joseph McGuirk, DO
Phone: 913-588-9031
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Miguel-Angel Perales, MD
Phone: 212-639-8682
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oakland, California 94609
Principal Investigator: Mark Walters, MD
Phone: 510-428-3374
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Lori Maness-Harris, MD
Phone: 402-559-3742
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Philadelphia, Pennsylvania 19104
Principal Investigator: Ran Reshef
Phone: 215-349-8940
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Niketa Shah
Phone: 551-580-5605
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: John McCarty, MD
Phone: 804-828-4596
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: William Hogan, MD
Phone: 507-284-2176
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Saint Louis, Missouri 63110
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Saint Petersburg, Florida 33701
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Salt Lake City, Utah 84132
Principal Investigator: Michael Pulsipher
Phone: 801-588-2680
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San Antonio, Texas 78229
Principal Investigator: Robert Sanders, MD
Phone: 201-575-7268
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San Francisco, California 94143
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Stanford, California 94305
Phone: 650-725-4626
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Tampa, Florida 33612
Principal Investigator: Joseph Pidala
Phone: 813-745-2556
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Wilmington, Delaware 19803
Principal Investigator: E. Anders Kolb, MD
Phone: 302-651-5567
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